Z-1494-2013 Class II Terminated
FDA device recall Z-1494-2013 was initiated by Stryker Instruments Div. Of Stryker Corporation on May 23, 2013 and is designated Class II. Reason for recall: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for… The recall status is terminated (terminated Apr 14, 2014). Affected quantity: 21,660 units (2166 boxes).
Recall details
- Product Type
- Devices
- Report Date
- Jun 12, 2013
- Initiation Date
- May 23, 2013
- Termination Date
- Apr 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,660 units (2166 boxes)
Product description
Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Reason for recall
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
Distribution pattern
USA Nationwide Distribution
Code information
1005105, 1009214, 1104308, 1006130, 1010260, 1104312, 1007152, 1012346, 1105378, 1007163, 1012303, 1106460, 1007164, 1101062, 1107542, 1008189, 1101063, 1108660, 1008188, 1102149, 1109760, 1009213, and 1103219.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1494-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026